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Moderate to Severe

Juvenile Idiopathic Arthritis

Non-Infectious

Intermediate, Posterior and Panuveitis

Active

Psoriatic Arthritis

Moderate to Severe

Hidradenitis Suppurativa

Refractory, Moderate to Severe

Atopic Dermatitis

Gastroenterology

Moderate to Severe

Crohn's Disease

Moderate to Severe

Pediatric Crohn's Disease

Moderate to Severe

Ulcerative Colitis

Moderate to Severe

Pediatric Ulcerative Colitis

Ophthalmology

Non-Infectious

Intermediate, Posterior and Panuveitis

For active psoriatic arthritis (PsA) in adult TNFi-IR patients1

Powerful disease
control2

RINVOQ achieved its ranked secondary endpoint of Minimal Disease Activity at Week 24, with response rates up to ~1 year2,3

IR=intolerance or inadequate response; TNFi=tumor necrosis factor inhibitor

RINVOQ achieved its ranked secondary endpoint of Minimal Disease Activity at Week 24, with response rates up to ~1 year2,3

IR=intolerance or inadequate response; TNFi=tumor necrosis factor inhibitor

Clinical Trial Overview

SELECT-PsA 2 Clinical Trial Overview

*P<0.001 RINVOQ vs placebo2

SELECT-PsA 2 Study Design Intro:1

24-week, double-blind, placebo-controlled study of 642 adult patients with moderate to severe active PsA who had an inadequate response or intolerance to at least one biologic DMARD. Patients were randomized to receive upadacitinib or placebo. The primary endpoint was proportion of patients achieving ACR20 response at Week 12 vs placebo.

ACR=American College of Rheumatology; ACR20=improvement of at least 20% in tender joint count, swollen joint count, and at least 3 of the 5 other core criteria, including patient and physician global assessments, health assessment questionnaire — disability index (HAQ‑DI), pain assessment, and high‑sensitivity C‑reactive protein (hs‑CRP); bDMARD=biologic disease‑modifying antirheumatic drug; DMARD=disease‑modifying antirheumatic drug; IR=intolerance or inadequate response; NRI=non‑responder imputation; PsA=psoriatic arthritis; QD=once per day; TNFi=tumor necrosis factor inhibitor

Minimal disease activity ACHIEVED
AT WEEK 24 WITH RESPONSE RATES
at WEEK 562,3

Minimal Disease Activity (MDA) is achieved when meeting 5 of 7 criteria:4

  • Tender joint count ≤1
  • Swollen joint count ≤1
  • PASI ≤1 or BSA-Psoriasis ≤3%
  • Pain NRS ≤1.5 (0—10 NRS)
  • Patient Global Disease Activity NRS ≤2 (0—10 NRS)
  • HAQ-DI ≤0.5
  • LEI ≤1

Get a summary of
the MDA data

SELECT-PsA 2: MDA over time3

A study in biologic DMARD-IR patients

RINVOQ is indicated for TNFi-IR patients

SELECT-PsA 2: MDA over time2

A study in biologic DMARD-IR patients

RINVOQ is indicated for TNFi-IR patients

SELECT-PsA 1: MDA over time SELECT-PsA 1: MDA over time SELECT-PsA 1: MDA over time

~25% of RINVOQ patients achieved MDA at Week 243,*

Nearly 30% of RINVOQ patients achieved MDA at ~1 year3

Data LIMITATIONS:4 Data labeled as a ranked secondary endpoint were multiplicity controlled for comparisons. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.

~25% of RINVOQ patients achieved MDA at Week 243,*

Nearly 30% of RINVOQ patients achieved MDA at ~1 year3

RINVOQ SAFETY DATA

Review the safety profile of RINVOQ,
including both short- and long-term analyses

IMPORTANT SAFETY
INFORMATION & INDICATION1

INDICATION1

RINVOQ is indicated for the treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.

Limitation of Use: Use of RINVOQ in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended.

SERIOUS INFECTIONS

  • Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before RINVOQ use and during therapy. Consider treatment for latent TB infection prior to RINVOQ use.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis.
  • Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

MORTALITY

MALIGNANCIES

MAJOR ADVERSE CARDIOVASCULAR EVENTS

THROMBOSIS

HYPERSENSITIVITY

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

EMBRYO-FETAL TOXICITY

VACCINATION

LACTATION

HEPATIC IMPAIRMENT

ADVERSE REACTIONS

REFERENCES

  1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
  2. Mease PJ, Lertratanakul A, Anderson JK, et al. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. 2021;80(3):312-320.
  3. Mease PJ, Lertratanakul A, Papp KA, et al. Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study. Rheumatol Ther. 2021;8(2):903-919. doi:10.1007/s40744-021-00305-z.
  4. Mease PJ, Lertratanakul A, Anderson JK, et al. Supplement - Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. 2021;80(3):312-320.

INDICATION & LIMITATION OF USE1

RINVOQ is indicated for the treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.

Limitation of Use: Use of RINVOQ in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine, is not recommended.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCIES, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt RINVOQ until the infection is

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCIES, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant

INDICATION & LIMITATION OF USE1

RINVOQ is indicated for the treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.

Limitation of Use: Use of RINVOQ in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine, is not recommended.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCIES, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt RINVOQ until the infection is

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCIES, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant

IMPORTANT SAFETY
INFORMATION & INDICATION1

INDICATION1

RINVOQ is indicated for the treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.

Limitation of Use: Use of RINVOQ in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended.

SERIOUS INFECTIONS

  • Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before RINVOQ use and during therapy. Consider treatment for latent TB infection prior to RINVOQ use.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis.
  • Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

MORTALITY

MALIGNANCIES

MAJOR ADVERSE CARDIOVASCULAR EVENTS

THROMBOSIS

HYPERSENSITIVITY

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

EMBRYO-FETAL TOXICITY

VACCINATION

LACTATION

HEPATIC IMPAIRMENT

ADVERSE REACTIONS